Understanding Clause 5.3: Organizational Roles, Responsibilities, and Authorities in ISO 9001:2015

Clause 5.3 of ISO 9001:2015 mandates that top management ensure that roles, responsibilities, and authorities within the organization are clearly defined and communicated. This ensures the effective implementation of the Quality Management System (QMS) and alignment with strategic goals.

Requirements of Clause 5.3

To comply with Clause 5.3, an organization must:

1. Define and Communicate Roles and Responsibilities: Clearly establish responsibilities and authorities for employees at all levels.

2. Ensure QMS Conformance: Assign responsibilities to ensure compliance with ISO 9001 requirements.

3. Report on QMS Performance: Designate individuals responsible for reporting on QMS performance and improvement opportunities.

4. Promote Customer Focus: Assign responsibilities ensuring customer requirements are met.

5. Maintain Documented Information: Keep records of assigned roles and responsibilities.

What Needs to Be in Place?

To demonstrate compliance with Clause 5.3, the following elements should be established:

• Organizational Chart: A visual representation of roles and reporting structures.

• Job Descriptions: Detailed documentation outlining responsibilities, authorities, and clear expectations for each role.

• Responsibility Matrices: A RACI (Responsible, Accountable, Consulted, Informed) chart to clarify role distribution.

• Employee Acknowledgment Forms: Signed documents confirming employees understand and accept their responsibilities.

• Training Records: Evidence of employees receiving training on their roles within the QMS.

Objective Evidence for Audits

During an audit, organizations must present documented evidence that roles, responsibilities, and authorities are clearly established and communicated. Key pieces of evidence include:

• Approved job descriptions with responsibilities related to the QMS.

• Signed acknowledgment forms confirming employees are aware of their responsibilities.

• Meeting minutes or records of discussions about role assignments.

• Performance review records indicating evaluation of QMS-related responsibilities.

• Reports on QMS performance provided by designated personnel.

Example: Job Description and Employee Acknowledgment

Job Title: Quality Manager

Department: Quality Assurance

Reports To: Director of Operations

Key Responsibilities:

• Ensure compliance with ISO 9001:2015 standards.

• Monitor and report on QMS performance and suggest improvements.

• Train and communicate quality policies and objectives to employees.

• Lead internal audits and corrective actions.

• Promote customer focus and satisfaction.

Employee Acknowledgment:

I, [Employee Name], acknowledge that I have read and understood my responsibilities as outlined in this job description. I agree to perform these duties in compliance with the organization’s QMS and ISO 9001:2015 requirements.

Employee Signature: _______________Date: _______________

By implementing Clause 5.3 effectively, organizations can ensure accountability, enhance performance, and drive continuous improvement within their QMS.